Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3007498452 • Hangzhou, Zhejiang • CHINA
FEI Number
3007498452
Location
Hangzhou, Zhejiang
Country
CHINAAddress
658 Bin'An Road, Binjiang District, Hangzhou, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2013 | 60WCR31PYRANTEL PAMOATE (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 7/31/2013 | 60WDT31PYRANTEL PAMOATE (ANTHELMINTIC) | San Francisco District Office (SAN-DO) | |
| 5/8/2013 | 60WCY31PYRANTEL PAMOATE (ANTHELMINTIC) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 3/21/2013 | 60WQT31PYRANTEL PAMOATE (ANTHELMINTIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. (FEI: 3007498452) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2013 to 9/30/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.'s FEI number is 3007498452.
What types of violations has Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. received?
Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.